Z-0225-2026 Class II Ongoing
FDA device recall Z-0225-2026 was initiated by UIH Technologies LLC on September 12, 2025 and is designated Class II. Reason for recall: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. The recall status is ongoing. Affected quantity: 4 unit.
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2025
- Initiation Date
- September 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 unit
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
Reason for Recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Distribution Pattern
US: OUS:
Code Information
UDI: (01)06971576832170/ Serial numbers: 11MI410003, 11MI410004, 11MI410005, 20MI410001